Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - maviret

Document Subject

Generated Narrative: MedicinalProductDefinition mp805dc9ddc6fcbad674af5feb9b21aed5

identifier: http://ema.europa.eu/identifier/EU/1/17/1213/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Maviret 100 mg/40 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-805dc9ddc6fcbad674af5feb9b21aed5

identifier: http://ema.europa.eu/identifier/EU/1/17/1213/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - maviret

Attesters

What is in this leaflet

1. What Maviret is and what it is used for
2. What you need to know before you take Maviret
3. How to take Maviret
4. Possible side effects
5. How to store Maviret
6. Contents of the pack and other information

Maviret is an antiviral medicine used to treat adults and children 3 years and older with long-term ( chronic ) hepatitis C. This is an infectious disease that affects the liver, caused by the hepatitis C virus. Maviret contains the active substances glecaprevir and pibrentasvir. Maviret works by stopping the hepatitis C virus from multiplying and infecting new cells. This allows the infection to be eliminated from the body.

Do not take Maviret if:

you are allergic to glecaprevir, pibrentasvir or any of the other ingredients of this medicine (listed in section 6).

you have severe liver problems other than from hepatitis C.

you are taking the following medicines:

atazanavir (for HIV infection)

atorvastatin or simvastatin (to lower blood cholesterol)

carbamazepine, phenobarbital, phenytoin, primidone (normally used for epilepsy)

dabigatran etexilate (to prevent blood clots)

ethinyl oestradiol-containing medicines (such as contraception medicines, including vaginal rings, transdermal patches, and tablets)

rifampicin (for infections)

St. John s wort (Hypericum perforatum) (herbal remedy used for mild depression). Do not take Maviret if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Maviret. Warnings and precautions Talk to your doctor if you have the following because your doctor may want to check you more closely:

liver problems other than hepatitis C

current or previous infection with the hepatitis B virus

diabetes. You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes treatment after starting Maviret. Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Maviret. Blood tests Your doctor will test your blood before, during and after your treatment with Maviret. This is so that your doctor can decide if:

you should take Maviret and for how long

your treatment has worked and you are free of the hepatitis C virus. Children Do not give this medicine to children under 3 years of age or weighing less than 12 kg. The use of Maviret in children under 3 years of age or weighing less than 12 kg has not yet been studied. Other medicines and Maviret Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor or pharmacist before taking Maviret, if you are taking any of the medicines in the table below. The doctor may need to change your dose of these medicines. Medicines you must tell your doctor about before taking Maviret Medicine Purpose of the medicine ciclosporin, tacrolimus to suppress the immune system darunavir, efavirenz, lopinavir, ritonavir for HIV infection digoxin for heart problems fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin to lower blood cholesterol warfarin and other similar medicines* to prevent blood clots *Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Maviret. Pregnancy and contraception The effects of Maviret during pregnancy are not known. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine, as the use of Maviret in pregnancy is not recommended. Contraceptive medicines that contain ethinylestradiol must not be used in combination with Maviret. Breast-feeding Talk to your doctor before taking Maviret if you are breast-feeding. It is not known whether the two medicines in Maviret pass into breast milk. Driving and using machines Maviret should not affect your ability to drive or use any tools or machines. Maviret contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Maviret contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long you need to take Maviret for. Maviret tablets are intended for adults, children 12 years and older, or children weighing 45 kg or more. Maviret coated granules are intended for children aged 3 years to less than 12 years and weighing 12 kg to less than 45 kg. How much to take The recommended dose for adults, children aged 12 years and older, or children weighing at least 45 kg is three tablets of Maviret 100 mg/40 mg taken together, once a day. Three tablets in one blister is the daily dose. How to take

Take the tablets with food.

Swallow the tablets whole.

Do not chew, crush or break the tablets as it may affect the amount of Maviret in your blood. If you are sick (vomit) after taking Maviret it may affect the amount of Maviret in your blood. This may make Maviret work less well.

If you vomit less than 3 hours after taking Maviret, take another dose.

If you vomit more than 3 hours after taking Maviret, you do not need to take another dose until your next scheduled dose. If you take more Maviret than you should If you accidentally take more than the recommended dose, contact your doctor or go to the nearest hospital straight away. Take the medicine pack with you so that you can show the doctor what you have taken. If you forget to take Maviret It is important not to miss a dose of this medicine. If you do miss a dose, work out how long it is since you should have last taken Maviret:

If you notice within 18 hours of the time you usually take Maviret, take the dose as soon as possible. Then take the next dose at your usual time.

If you notice 18 hours or more after the time you usually take Maviret, wait and take the next dose at your usual time. Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or pharmacist if you notice any of the following side effects: Very common: may affect more than 1 in 10 people

feeling very tired (fatigue)

headache Common: may affect up to 1 in 10 people

feeling sick (nausea)

diarrhoea

feeling weak or lack of energy (asthenia)

increase in a laboratory test of liver function (bilirubin) Uncommon: may affect up to 1 in 100 people

swelling of the face, lips, tongue, throat, abdomen, arms or legs Not known: cannot be estimated from the available data

itching Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Maviret contains

The active substances are glecaprevir and pibrentasvir. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir.

The other ingredients are:

Tablet core: copovidone (Type K 28), vitamin E polyethylene glycol succinate, silica, anhydrous colloidal, propylene glycol monocaprylate (type II), croscarmellose sodium, sodium stearyl fumarate.

Tablet film-coating: hypromellose (E464), lactose monohydrate, titanium dioxide, macrogol 3350, iron oxide red (E172). Maviret contains lactose and sodium. See section 2. What Maviret looks like and contents of the pack Maviret tablets are pink, oblong, curved on both sides (biconvex), film-coated tablets (tablets) with dimensions of 18.8 mm x 10.0 mm and debossed on one side with NXT . Maviret tablets are packed into foil blisters, each containing 3 tablets. Maviret is available in a pack of 84 tablets as 4 cartons, each containing 21 film-coated tablets. Marketing Authorisation Holder AbbVie Deutschland GmbH & Co. KG Knollstrasse 67061 Ludwigshafen Germany Manufacturer AbbVie Deutschland GmbH & Co. KG Knollstrasse 67061 Ludwigshafen Germany or AbbVie Logistics B.V Zuiderzeelaan 8017 JV Zwolle Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AbbVie SA T l/Tel: +32 10 477Lietuva AbbVie UAB Tel: +370 5 205 3

.: +359 2 90 30 Luxembourg/Luxemburg AbbVie SA Belgique/Belgien T l/Tel: +32 10 477 esk republika AbbVie s.r.o. Tel: +420 233 098 Magyarorsz g AbbVie Kft. Tel.: +36 1 455 8Danmark AbbVie A/S Tlf: +45 72 30-20-Malta V.J.Salomone Pharma Limited Tel: +356 22983Deutschland AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (geb hrenfrei) Tel: +49 (0) 611 / 1720-0 Nederland AbbVie B.V. Tel: +31 (0)88 322 2Eesti AbbVie O Tel: +372 623 1Norge AbbVie AS Tlf: +47 67 81 80
AbbVie . . : +30 214 4165 sterreich AbbVie GmbH Tel: +43 1 20589-0 Espa a AbbVie Spain, S.L.U. Tel: +34 91 384 09 Polska AbbVie Sp. z o.o. Tel.: +48 22 372 78 France AbbVie T l: +33 (0)1 45 60 13 Portugal AbbVie, Lda. Tel: +351 (0)21 1908Hrvatska AbbVie d.o.o. Tel: +385 (0)1 5625 Rom nia AbbVie S.R.L. Tel: +40 21 529 30 Ireland AbbVie Limited Tel: +353 (0)1 4287Slovenija AbbVie Biofarmacevtska dru ba d.o.o. Tel: +386 (1)32 08 sland Vistor hf. S mi: +354 535 7Slovensk republika AbbVie s.r.o. Tel: +421 2 5050 0Italia AbbVie S.r.l. Tel: +39 06 928Suomi/Finland AbbVie Oy Puh/Tel: +358 (0)10 2411
Lifepharma (Z.A.M.) Ltd : +357 22 34 74 Sverige AbbVie AB Tel: +46 (0)8 684 44 Latvija AbbVie SIA Tel: +371 67605United Kingdom (Northern Ireland) AbbVie Deutschland GmbH & Co. KG Tel: +44 (0)1628 561This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: